K221550
- 510(k) number
- K221550
- Device name
- Evidence MultiSTAT DOA Urine MultiPlex
- Applicant
- Randox Laboratories Limited GB
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2023-10-05
- Date received
- 2022-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K221550.pdf
Official FDA record: K221550
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.